There is one clinical trial.
The purpose of this study is to assess the efficacy and safety of treatment with various dose levels of TAK-906 in adult participants with gastroparesis compared with placebo during 12 weeks of treatment.
Description: The ANMS GCSI-DD composite score includes score of nausea, early satiety, upper abdominal pain and postprandial fullness. The severity scores of these symptoms range from 0 ( none) to 4 (very severe).
Measure: Change From Baseline in American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index-Daily Diary (ANMS GCSI-DD) Composite Score at Week 12 Time: Baseline and Week 12Description: The ANMS GCSI-DD composite score includes score of nausea, early satiety, upper abdominal pain, and postprandial fullness. The severity scores of these symptoms range from 0 ( none) to 4 (very severe).
Measure: Percentage of Participants with At least 50% Reduction From Baseline in ANMS GCSI-DD Composite Score at Week 12 Time: Baseline and Week 12Description: The ANMS GCSI-DD nausea symptom score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.
Measure: Change from Baseline in the ANMS GCSI-DD Nausea Symptom Score at Week 12 Time: Baseline and Week 12Description: The ANMS GCSI-DD early satiety symptom score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.
Measure: Change from Baseline in the ANMS GCSI-DD Early Satiety Symptom Score at Week 12 Time: Baseline and Week 12Description: The ANMS GCSI-DD postprandial fullness symptom score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.
Measure: Change from Baseline in the ANMS GCSI-DD Postprandial Fullness Symptom Score at Week 12 Time: Baseline and Week 12Description: The ANMS GCSI-DD upper abdominal pain symptom score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.
Measure: Change from Baseline in the ANMS GCSI-DD Upper Abdominal Pain Symptom Score at Week 12 Time: Baseline and Week 12Description: The vomiting score assesses the number of vomiting episodes during the day.
Measure: Change from Baseline in the ANMS GCSI-DD Recorded Vomiting Frequency at Week 12 Time: Baseline and Week 12Description: The bloating severity scale score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.
Measure: Change from Baseline in the ANMS GCSI-DD Bloating Severity Scale Score at Week 12 Time: Baseline and Week 12Description: The ANMS GCSI-DD total score quantifies the incidence and severity of symptoms, specifically nausea, early satiety, postprandial fullness, upper abdominal pain, bloating, and vomiting.
Measure: Change from Baseline in the ANMS GCSI-DD Total Score at Week 12 Time: Baseline and Week 12Description: Symptomatic weeks are weeks with average composite symptom score assessed as >mild [ANMS GCSI-DD Score ≥2]).
Measure: Percentage of Symptomatic Weeks Time: Up to 12 weeksDescription: PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation). Higher scores indicate higher symptom severity.
Measure: Change from Baseline in the Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) Total Score at Week 12 Time: Baseline and Week 12Description: The ANMS GCSI-DD gastroparesis symptoms score ranges from 0-none to 4-very severe. High scores reflect greater symptom severity.
Measure: Change from Baseline in the ANMS GCSI-DD Severity of Gastroparesis Symptoms Score at Week 12 Time: Baseline and Week 12